Phase 3
Completed N=191
NINDS CRC Chronic Migraine Treatment Trial
Source: ClinicalTrials.gov NCT00772031 ↗Enrolled (actual)
191
Serious AEs
6.3%
Results posted
Jan 2012
Primary outcomePrimary: Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline — 4.4; 4.7 Moderate to severe headache days — p=0.77
Summary
The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline |
4.4; 4.7 | 0.77 |
| SECONDARY Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days |
37; 28 | — |
| SECONDARY Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days |
26; 23 | — |
| SECONDARY Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months |
0.3; 0.6 | — |
| SECONDARY Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months |
-3.18; -3.46 | 0.91 |
| SECONDARY Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months |
-0.7; -2.2 | — |
| SECONDARY Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months |
12.9; 5.9; -11.5; 11.0 | — |
| SECONDARY Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months |
8.9; 9.8 | — |
Eligibility Criteria
Inclusion Criteria
- History of chronic migraine for at least 6 months
- Age ≥ 18 years and age of migraine onset 60 or younger
- EKG performed in the last 12 months
Exclusion Criteria
- Prior neuro-imaging suggesting secondary structural causes of headache
- Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
- Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
- History of kidney failure or nephrolithiasis
- A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
- Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
- Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
- Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months
Data sourced from ClinicalTrials.gov (NCT00772031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.